FDA.reportPublic FDA data

AirLife™

Primary DI
10889483604045
Brand
AirLife™
Company
AIRLIFE
Model
NIV043L
Catalog number
NIV043L
Device description
Non Invasive Ventilation (NIV) Non-Vented Full Face Mask with Anti-Asphyxiation Valve (Large)
Published
2025-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483604049PackageGS110In Commercial Distribution
10190752139428PreviousGS10
10889483604045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948360404930889483604049
1019075213942810190752139428
1088948360404510889483604045

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752146662Vital Signs™5612VS5612VS2019-12-20
10889483586761Vital Signs™5612VS5612VS2025-02-12
10889483589175BROSELOW™7730FLY7730FLY2025-03-07
10889483589182BROSELOW™7730FLYY7730FLYY2025-03-13
10889483598276BROSELOW™BPOC01ABPOC01A2025-03-13
10190752144743AirLife™4S78XX004S78XX002020-01-15
10190752152946AirLife™10855-85510855-8552021-05-07
10889438651308AirlifeCK-25-0026CK-25-00262026-04-15
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483570999AirLife™0021730021732025-02-20
10889483572283AirLife™1006-H051006-H052025-02-17
10889483572528AirLife™10155N-50410155N-5042025-02-12
10889483572559AirLife™10225-50410225-5042025-02-12
10889483572658AirLife™10303N-50410303N-5042025-03-05
10889483572672AirLife™10333-50410333-5042025-02-17
10889483572818AirLife™10604-85510604-8552025-02-12
10889483572825AirLife™10608-70110608-7012025-02-12
10889483572870AirLife™10746-85510746-8552025-02-12
10889483572900AirLife™10794-H1210794-H122025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102679MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676247DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676254DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676261DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676377DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676384DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676391DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676407DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676360DIMARHMC PREMEDICAL SPACBK2025-03-20
10889483603987AirLife™AIRLIFECBK2025-02-26
10889483603994AirLife™AIRLIFECBK2025-02-26
10889483604007AirLife™AIRLIFECBK2025-02-26
10889483604052AirLife™AIRLIFECBK2025-02-26
10889483604069AirLife™AIRLIFECBK2025-02-26
10889483604076AirLife™AIRLIFECBK2025-02-26
10889483604083AirLife™AIRLIFECBK2025-02-26
10889483604090AirLife™AIRLIFECBK2025-02-26
10190752187825iFlowVYAIRE MEDICAL, INC.CBK2024-11-05